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NCT00696163 Clinical Trial

Observational Study to Assess the Quality of Life and Clinical Outcomes in Subjects Using NovoMix® 30 for the Treatment of Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— IMPROVE Life  

Official title:
A Multicentre, Open Label, Nonrandomised, Non- Interventional, A Multicentre, Open Label, Nonrandomised, Non- Interventional, Observational Study to Evaluate the Quality of Life and Clinical Outcomes in Subjects Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00696163
Other study ID # BIASP-3555
Secondary ID
Status Completed
Phase N/A
First received June 10, 2008
Last updated October 27, 2016
Start date April 2008
Est. completion date March 2009

Study information
Verified date October 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Observational

Clinical Trial Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India.

Recruitment information / eligibility
Status Completed
Enrollment 24975
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Type 2 diabetes, including newly-diagnosed who have never received insulin or an insulin analogue before, at the discretion of the physician.

Exclusion Criteria:

- Currently treated with NovoMix® 30

- Subjects who are unlikely to comply with protocol requirements

- Previously enrolled in this study

- Hypersensitivity to biphasic insulin aspart or to any of the excipients

- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart 30
Being an observational study, dose of NovoMix 30 will be according to treating physician's discretion

Locations
Country Name City State
India Novo Nordisk Investigational Site Bangalore

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Quality of Life from baseline (using QoLD questionnaire) From baseline to 26 weeks of treatment No
Secondary Safety After 26 weeks Yes
Secondary Efficacy After 26 weeks Yes
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